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Trial registered on ANZCTR


Registration number
ACTRN12610000927022
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
1/11/2010
Date last updated
1/06/2024
Date data sharing statement initially provided
18/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
Scientific title
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
Secondary ID [1] 252938 0
clinicaltrials. gov. NCT00678327
Universal Trial Number (UTN)
Trial acronym
RATHL HD8
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 258469 0
Condition category
Condition code
Cancer 258635 258635 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects follow different treatment courses depending on outcomes of Positron Emission Tomography (PET) scans at various stage during the trial.


The drugs used in treatment are as follows:
bleomycin sulfate
filgrastim
pegfilgrastim
cyclophosphamide
dacarbazine
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vinblastine
vincristine sulfate

Subjects undergo 2 cycles of ABVD and then have a PET scan. PET negative patients are subsequently randomised between ABVD for 4 cycles of AVD (25mg/m2 doxorubicin intravenously (i.v) days 1,15; 6mg/m2 vinblastine i.v days 1,15; Dacarbazine 375mg/m2 i.v days 1,15) for 4 cycles, before progressing to response assessment. PET positive patients undergo either 4-6 14 day cycles of BEACOPP-14 (25mg/m2 doxorubicin iv day 1; cyclophosphamide 650mg/m2 iv day 1; Etoposide 100mg/m2 i.v days 1-3; Procarbazine 100mg/m2 per oral (po) days 1-7; Prednisolone 80mg/m2 po days 1-7; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg subcutaneously (s.c) days 9-13 or Peg filgastrim single dose) or 3-4 cycles of 21 day BEACOPP escalated (35mg/m2 doxorubicin i.v day 1; cyclophosphamide 1250mg/m2 i.v day 1; Etoposide 200mg/m2 i.v days 1-3; Procarbazine 100mg/m2 po days 1-7; Prednisolone 40mg/m2 po days 1-14; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg s.c days 9-13 or Peg filgastrim single dose)(choice of therapy determined in advance by centre) before progressing to another PET scan. PET negative patients on this scan undergo either 2 cycles of BEACOPP-14 or 1 more cycle of BEACOPP-escalated. PET positive patients have either radiation or salvage therapy at Investigator discretion before progressing to response assessment.
Intervention code [1] 257464 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259479 0
Progression-free survival
Timepoint [1] 259479 0
3 years
Secondary outcome [1] 266060 0
overall survival
Timepoint [1] 266060 0
5 years following initial PET scan following 2 cycles of ABVD (Doxorubicin 25mg/m2 iv days 1,15; Bleomycin 10,000units/m2 iv days 1,15; Vinblastine 6mg/m2 iv days 1,15; Dacarbazine 375mg/m2 iv days 1,15)
Secondary outcome [2] 266061 0
toxicity (acute and chronic) using National Cancer Institute criteria
Timepoint [2] 266061 0
5 years following initial PET scan following 2 cycles of ABVD

Eligibility
Key inclusion criteria
Histologically confirmed classical Hodgkin lymphoma (HL) according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted). All histology will be reviewed by a central pathology panel for the group concerned
2. Aged 18 or above
3. Clinical stage IIB, IIIA, IIIB or IV, or Clinical stage IIA with adverse features:
-bulk mediastinal disease, defined as maximal transverse diameter of mass >0.33 of the internal thoracic diameter at D5/6 interspace on routine chest X-ray
-outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
-more than two sites of disease
-other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
4. No previous chemotherapy, radiotherapy or other investigational drug for HL
5. Performance status 0-3
6. Adequate bone marrow function with platelets > 100x10e9/l; neutrophils > 1.5x10e9/l at the time of study entry unless lower numbers are attributed to bone marrow infiltration by lymphoma
7. Serum creatinine less than 150% of the upper limit of normal, serum bilirubin less than twice the upper limit of normal and transaminases < 2.5× upper limit of normal unless attributed to lymphoma
8. Patients with a significant history of ischaemic heart disease or hypertension must have an acceptable left ventricular ejection fraction (LVEF) =50%
9. Life expectancy > 3 months
10. All patients of childbearing potential are willing to use adequate contraceptive precautions
11. Written, informed consent
12. Access to PET-CT scanning
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Poorly controlled Diabetes mellitus
2. Other concurrent uncontrolled medical condition
3. Pregnant or lactating
4. Known central nervous system or meningeal involvement by the lymphoma
5. Cardiac contra-indication to doxorubicin: abnormal contractility on echocardiography or nuclear medicine examination (MUGA)
6. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy)
7. General status that does not allow the administration of a full course of chemotherapy according to the investigator
8. Previous history of active malignant disease other than fully excised basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years
9. Known positive serology for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors)
10. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central enrolment through the United Kingdom and allocation of trial Identification number. Follwoing enrolment all data will be collected under trial identification number.

Study is not blinded therefore no concealment of allocated treatment required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequential number allocation in order patients are registered.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2010
Actual
9/09/2010
Date of last participant enrolment
Anticipated
Actual
4/12/2012
Date of last data collection
Anticipated
21/07/2021
Actual
30/04/2024
Sample size
Target
1200
Accrual to date
Final
1203
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS
Recruitment hospital [1] 8150 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 8151 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 8152 0
Border Medical Oncology - Albury
Recruitment hospital [4] 8153 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 8154 0
Westmead Hospital - Westmead
Recruitment hospital [6] 8155 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 8156 0
Prince of Wales Hospital - Randwick
Recruitment hospital [8] 8157 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 8158 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 8159 0
The Canberra Hospital - Garran
Recruitment hospital [11] 8160 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [12] 8161 0
Royal Hobart Hospital - Hobart
Recruitment hospital [13] 8162 0
Western Hospital - Footscray - Footscray
Recruitment hospital [14] 8163 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 16211 0
3000 - Melbourne
Recruitment postcode(s) [2] 16212 0
2139 - Concord
Recruitment postcode(s) [3] 16213 0
3690 - Wodonga
Recruitment postcode(s) [4] 16214 0
2050 - Camperdown
Recruitment postcode(s) [5] 16215 0
2145 - Westmead
Recruitment postcode(s) [6] 16216 0
2065 - St Leonards
Recruitment postcode(s) [7] 16217 0
2031 - Randwick
Recruitment postcode(s) [8] 16218 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 16219 0
6009 - Nedlands
Recruitment postcode(s) [10] 16220 0
2605 - Garran
Recruitment postcode(s) [11] 16221 0
0810 - Tiwi
Recruitment postcode(s) [12] 16222 0
7000 - Hobart
Recruitment postcode(s) [13] 16223 0
3011 - Footscray
Recruitment postcode(s) [14] 16224 0
4870 - Cairns
Recruitment outside Australia
Country [1] 2986 0
United Kingdom
State/province [1] 2986 0
London

Funding & Sponsors
Funding source category [1] 257920 0
Government body
Name [1] 257920 0
National Health and Medical Research Council
Country [1] 257920 0
Australia
Primary sponsor type
University
Name
University College
Address
Gower St
London WC1E 6BT
Country
United Kingdom
Secondary sponsor category [1] 257109 0
Other Collaborative groups
Name [1] 257109 0
Australasian Leukaemia and Lymphoma Group
Address [1] 257109 0
Level 2/10 St Andrews Place
East Melbourne, VIC,3002
Country [1] 257109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259933 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 259933 0
Ethics committee country [1] 259933 0
Australia
Date submitted for ethics approval [1] 259933 0
Approval date [1] 259933 0
14/07/2011
Ethics approval number [1] 259933 0
Ethics committee name [2] 297794 0
Sydney South West Area HREC
Ethics committee address [2] 297794 0
Ethics committee country [2] 297794 0
Australia
Date submitted for ethics approval [2] 297794 0
16/12/2009
Approval date [2] 297794 0
16/12/2009
Ethics approval number [2] 297794 0
Ethics committee name [3] 297795 0
Metro South Hospital and Health Service HREC
Ethics committee address [3] 297795 0
Ethics committee country [3] 297795 0
Australia
Date submitted for ethics approval [3] 297795 0
20/05/2010
Approval date [3] 297795 0
08/12/2009
Ethics approval number [3] 297795 0
09/QPAH/302
Ethics committee name [4] 297796 0
Northern Territories Department of Health HREC
Ethics committee address [4] 297796 0
Ethics committee country [4] 297796 0
Australia
Date submitted for ethics approval [4] 297796 0
Approval date [4] 297796 0
15/07/2011
Ethics approval number [4] 297796 0
2011/1609
Ethics committee name [5] 297797 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [5] 297797 0
Ethics committee country [5] 297797 0
Australia
Date submitted for ethics approval [5] 297797 0
Approval date [5] 297797 0
10/02/2011
Ethics approval number [5] 297797 0
2010/153
Ethics committee name [6] 297798 0
University of Tasmania HREC
Ethics committee address [6] 297798 0
Ethics committee country [6] 297798 0
Australia
Date submitted for ethics approval [6] 297798 0
Approval date [6] 297798 0
03/11/2011
Ethics approval number [6] 297798 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31820 0
A/Prof Judith Trotman
Address 31820 0
Concord Repatriation General Hospital Hospital Road Concord, NSW, 2139
Country 31820 0
Australia
Phone 31820 0
+61 2 9767 7243
Fax 31820 0
Email 31820 0
Judith.Trotman@health.nsw.gov.au
Contact person for public queries
Name 15067 0
Delaine Smith
Address 15067 0
ALLG
35 Elizabeth Street
Richmond
VIC 3121
Country 15067 0
Australia
Phone 15067 0
+61 3 8373 9701
Fax 15067 0
Email 15067 0
Delaine.smith@allg.org.au
Contact person for scientific queries
Name 5995 0
Judith Trotman
Address 5995 0
Concord Repatriation General Hospital
Hospital Road
Concord, NSW, 2139
Country 5995 0
Australia
Phone 5995 0
+61 2 9767 7243
Fax 5995 0
Email 5995 0
Judith.Trotman@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.